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Handiflex is a tilt table which provide the means for the user to go from the horizontal to the near vertical position to access components for redeveloping muscles or increasing the range of motion of the joints.

The user can exercise different muscle groups at different degrees of inclination.

Handiflex is a tilt table

This document is a 510(k) clearance letter from the FDA for a device called "HANDIFLEX." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, the letter does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document only provides:

• The FDA's decision to clear the device for marketing.
• The device name: HANDIFLEX.
• The intended indications for use: "Handiflex is a tilt table which provide the means for the user to go from the horizontal to the near vertical position to access components for redeveloping muscles or increasing the range of motion of the joints. The user can exercise different muscle groups at different degrees of inclination."
• General regulatory information.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, ground truth, or expert qualifications as these are not present in the provided text.

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